Quetiapine

Product NDC: 42291-695
11-digit product format: 422910695
Labeler code: 42291
Product ID: 42291-695_4871de67-6df0-716d-e063-6394a90a2195
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvKARE
Application: ANDA077745
Marketing category: ANDA
Marketing start: 2022-05-25
Marketing end: 2026-06-30
Substance: QUETIAPINE FUMARATE
Active strength: 25 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42291-695		D	Discontinued by firm	2026-08-03
excluded package	package	42291-695	42291-695-10	D	Discontinued by firm	2026-08-03
excluded package	package	42291-695	42291-695-90	D	Discontinued by firm	2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077745-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27
A077745-007	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A077745-001	AB
A077745-002	AB
A077745-003	AB
A077745-004	AB
A077745-005	AB
A077745-006	AB
A077745-007	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077745-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077745-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-006	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-007	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077745-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077745-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077745-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077745-004	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077745-005	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077745-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077745-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077745-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077745-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077745-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077745-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077745-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077745-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077745-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077745-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077745-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077745-005	AB	1	`03ed91905a0d…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5ef42f82-f087-0d2c-105f-f791ca69210e	Product name	8	20250729
21205abd-8c89-4943-9f85-908f3d4fc3bb	Product name	5	20230501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-695-10	Quetiapine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		12
42291-695-90	Quetiapine	90 in 1 BOTTLE	TABLET, FILM COATED	90		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-695-10	EA - Each	42291-695	0c6da67a-d567-4322-b02c-8b41e8ddf2f8	1	2014-05-02
42291-695-90	EA - Each	42291-695	ca8344ad-3c44-4fcc-b753-51a8009f9540	1	2023-02-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
POVIDONE K26/28	INACTIVE INGREDIENT	H7AGY1OJO8	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-695	QUETIAPINE TABLET, FILM COATED [AVKARE]	11	Current NDC, Legacy NDC, 2 package rows	20230117_8a3fc038-aad1-6404-6ead-a4a55127cf43.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine	QUETIAPINE	Teva Pharmaceuticals USA, Inc.	c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b	2025-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077745 application number: ANDA077745
Quetiapine	QUETIAPINE	Aphena Pharma Solutions - Tennessee, LLC	fdece055-aeb5-43d6-b730-54dd74bde304	2023-04-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077745 application number: ANDA077745
Quetiapine	QUETIAPINE	Proficient Rx LP	dd6b6088-943e-413b-9886-88dd9c622be4	2022-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077745 application number: ANDA077745
Quetiapine	QUETIAPINE	Proficient Rx LP	6258bbaf-4ac0-4621-b95e-e6b032aa0518	2020-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077745 application number: ANDA077745

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S3PL1B6UJ	QUETIAPINE FUMARATE	111974-72-2	QUETIAPINE FUMARATE
BGL0JSY5SI	QUETIAPINE	111974-69-7	Quetiapine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312743	QUEtiapine fumarate 100 MG Oral Tablet	PSN	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
312743	quetiapine 100 MG Oral Tablet	SCD	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
317174	quetiapine 200 MG Oral Tablet	SCD	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
312744	quetiapine 25 MG Oral Tablet	SCD	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
312745	quetiapine 300 MG Oral Tablet	SCD	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
616483	quetiapine 400 MG Oral Tablet	SCD	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
616487	quetiapine 50 MG Oral Tablet	SCD	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	8a3fc038-aad1-6404-6ead-a4a55127cf43	12
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	8a3fc038-aad1-6404-6ead-a4a55127cf43	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-695-10	42291069510	1000 TABLET, FILM COATED in 1 BOTTLE (42291-695-10)	2022-05-25	2026-06-30	No	No	Current
42291-695-90	42291069590	90 in 1 BOTTLE					Historical